MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ IV CATHETER; INTRAVASCULAR CATHETER

Model Number	381112
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd angiocath¿ iv catheter hub would not connect to the extension tubing during use.The following information was provided by the initial reporter, translated from (b)(6): "this is a report about a connection issue of angiocath.The customer reported as follows: this occurred in an outpatient pediatric setting on (b)(6) 2022.After catheter placement, the hcp connected it to non-bd¿s extension tubing (surplug ad) but it was not locked, spinning only.The hcp pressed it strongly and fixed it with a tape, and then removed it on (b)(6) 2022.The hcp is stating that there might be a defect on the catheter hub.".
Additional Manufacturer Narrative
H.6.Investigation: bd received a 24 gauge angiocath device from lot 9157626 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed that the thread's of the adapter were damaged.Based off the visual inspection the engineer was able to verify the reported defect.It was determined that there was a misalignment between the transfer arm and the chuck holder.The manufacturing facility has been notified of this incident and the findings.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd angiocath¿ iv catheter hub would not connect to the extension tubing during use.The following information was provided by the initial reporter, translated from japanese: "this is a report about a connection issue of angiocath.The customer reported as follows: this occurred in an outpatient pediatric setting on 01/06/2022.After catheter placement, the hcp connected it to non-bd¿s extension tubing (surplug ad) but it was not locked, spinning only.The hcp pressed it strongly and fixed it with a tape, and then removed it on 01/11/2022.The hcp is stating that there might be a defect on the catheter hub.".

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13385798
• Report Number: 9610048-2022-00003
• Device Sequence Number: 16572957
• Product Code: FOZ
• UDI-Device Identifier: 30382903811121
• UDI-Public: 30382903811121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 381112
• Device Catalogue Number: 381112
• Device Lot Number: 9157626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown